Associate Manufacturing - Downstream - Nights
Associate Manufacturing - Downstream - Nights
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$ 85625 - 85625
1 Vacancy
Job Description
Career Category
ManufacturingJob Description
Join Amgens Mission of Serving Patients
At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.
Our awardwinning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainlesssteel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best inclass drug substance manufacturing technologies with embedded industry 4.0 capabilities but it will also integrate sustainability innovations to reduce carbon and waste as part of Amgens plan to be a carbonneutral company by 2027.
Associate Manufacturing Downstream Nights
What you will do
Lets do this. Lets change the world. In this vital role you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC). The initial schedule will be MondayFriday approximately 6am to 4pm but the schedule could change based on business needs. The schedule will transition to a 12hour night shift as business needs dictate. Associates will be completing operations on the floor in our downstream area and are responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance.
With general direction the Associate will support all floor operations in accordance with cGMP practices.
Compliance:
- Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures SOPs Manufacturing Procedures MPs Job Hazard Analysis JHAs Code of Federal Regulations CFR) with strict adherence to safety and compliance
- Assure proper gowning and aseptic techniques are always followed
Process/Equipment/Facilities:
- Perform handson operations including setup cleaning sanitization monitoring of equipment and assigned area
- Run and monitor critical process tasks per assigned procedures
- Perform inprocess sampling operate analytical equipment and complete process documentation (Electronic Batch Records EBRs)
- Identify and escalate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions
- Perform documentation for assigned functions (i.e. equipment logs EBRs)
- Collaborate as part of a crossfunctional team (i.e. QA/QC F&E (Facilities & Engineering) PPIC Mfg. PD (Process Development) Regulatory etc. in completing production activities
- Maintain an organized clean and workable space
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The hardworking professionals we seek are team players with these qualifications.
Basic Qualifications:
- High School/GED 2 years manufacturing and/or other regulated environment experience OR
- Associates Degree 6 months manufacturing and/or other regulated environment experience OR
- Bachelors Degree
Preferred Qualifications:
- Completion of NC BioWorks Certification Program
- Experience in a regulated industry such as biotechnology or pharmaceutical
- Basic understanding and process experience in a cGMP manufacturing facility
- Basic knowledge of largescale biotechnology operations such as purification cell culture aseptic processing etc.
- Excellent verbal and written communication
- Proficient Microsoft Office skills and knowledge of other electronic systems such as EBR/MES Delta V and Electronic Quality Systems
- An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes
What you can expect of us
As we work to develop treatments that take care of others we also work to care for your professional and personal growth and wellbeing. From our competitive benefits to our collaborative culture well support your journey every step of the way.
In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen
As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.Salary Range
73359.00 USD 85625.00 USDRequired Experience:
IC
Employment Type
Full-Time
